Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
3 Class I (most serious) drug recalls reported in the last 30 days.
1,094 recalls
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Class II Ongoing
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
- Distribution
- Nationwide in the USA and Puerto Rico.
- Quantity
- 7344 bottles
- Recall started
- December 16, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0087-2023
-
Class II Ongoing
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 3…
Reason: Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Lots, distribution and details
- Product
- Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
- Lots / codes
- Lot: 91316 Exp. 02/2023
- Distribution
- Nationwide in the USA
- Quantity
- 3977 boxes
- Recall started
- November 16, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0071-2023
-
Class III Ongoing
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
Reason: Presence of Particulate Matter: Piece of metal found in a vial
Lots, distribution and details
- Lots / codes
- Lot: CTA210006, Exp. 02/2024
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 88080 vials
- Recall started
- September 26, 2022 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-1551-2022
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Class II Ongoing
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 6003…
Reason: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Lots, distribution and details
- Product
- Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
- Lots / codes
- Lot#: a) 3192827, Exp 10/31/2022; 3196136, Exp 12/31/2022; 3202198, Exp 07/31/2023; 3203658, Exp 07/31/2023; 3209114, Exp 11/30/2023; 3203851, Exp 02/29/2024; b) 3191254, Exp 09/30/2022; 3192820, Exp 09/30/2022; 3192822, Exp 10/31/2022; 3192824, Exp 10/31/2022; 3192825, Exp 10/31/2022; 3196141, Exp 01/31/2023; 3196143, Exp 02/28/2023; 3203870, Exp 11/30/2023; 3203871, Exp 02/29/2024; c) 3190636, Exp 09/30/2022; 3192813, Exp 09/30/2022; 3196132, Exp 12/31/2022; 3196133, Exp 12/31/2022; 3196138, Exp 01/31/2023; 3199702, Exp 03/31/2023; 3199703, Exp 03/31/2023
- Distribution
- USA Nationwide and Puerto Rico
- Quantity
- 177,439 bottles
- Recall started
- September 21, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1548-2022
-
Class II Ongoing
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
Reason: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Lots, distribution and details
- Product
- Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
- Lots / codes
- Lot#: 3192818, Exp 10/31/2022; 3199700, Exp 03/31/2023; 3203853, Exp 02/29/2024
- Distribution
- USA Nationwide and Puerto Rico
- Quantity
- 18,145 bottles
- Recall started
- September 21, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1547-2022
-
Class II Ongoing
Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765.
Reason: Labeling: Product Contains Undeclared API – product contains undeclared ethyl alcohol
Lots, distribution and details
- Lots / codes
- Lot # 015, 016, 017, 018, 018, 019, 020, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 031, 032, 033, 034, 035, 036, 037, 038.
- Distribution
- Distributed in VA, USA
- Quantity
- 350,000 bottles
- Recall started
- July 19, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1475-2022
-
Class II Ongoing
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
Reason: Labeling: Product Contains Undeclared API – product contains undeclared ethyl alcohol
Lots, distribution and details
- Product
- Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
- Lots / codes
- Lot # 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 250, 251, 252, 253, 254, 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273, 274, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 285, 286, 287, 288, 289, 290, 291, 292, 293, 294, 295, 296, 297, 298, 299, 300, 301, 302, 303, 304, 305, 306, 307, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 327, 328, 329, 330, 331, 332, 333, 334, 335, 336, 337, 338.
- Distribution
- Distributed in VA, USA
- Quantity
- 2,700,000 bottles
- Recall started
- July 19, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1474-2022
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Class II Ongoing
VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Lots / codes
- SKU: 903367
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1462-2022
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Class II Ongoing
QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Lots / codes
- SKU: 916922
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1461-2022
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Class II Ongoing
MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Lots / codes
- SKU: 900844
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1460-2022
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Class II Ongoing
QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Lots / codes
- SKU: 916058
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1459-2022
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Class II Ongoing
HYLANDS 4KIDS COLD N MUCUS RELIEF 4 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Lots / codes
- SKU: 999246
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1458-2022
-
Class II Ongoing
MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Lots / codes
- SKU: 903372
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1457-2022
-
Class II Ongoing
REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHRY 6FL OZ SKU 999559 VICKS JARABE COUGH CONGESTION 8FLOZ SKU 998933 distributed to specific Family Dolla…
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHRY 6FL OZ SKU 999559 VICKS JARABE COUGH CONGESTION 8FLOZ SKU 998933 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 917531; 900854; 999559; 998933
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1456-2022
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Class II Ongoing
QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Lots / codes
- SKU: 916001
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1455-2022
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Class II Ongoing
DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY NIGHT LGEL 20 CT SKU 902012 GS COLD FLU RELIEF NGHTTIME CHRY12FL OZ SKU 917523 RIC COLD FLU DAY TIME LIQ…
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY NIGHT LGEL 20 CT SKU 902012 GS COLD FLU RELIEF NGHTTIME CHRY12FL OZ SKU 917523 RIC COLD FLU DAY TIME LIQUID CAP 16 CT SKU 903037 ASP SEVERE COLD COUGH CITRUS 20CT SKU 902906 ASP SEVERE COLD ORANGE ZEST 20CT SKU 902908 ALKA SELTZER PLUS SEVERE COLD ORIG 20CT SKU 903333 AS PLUS SINUS ALLERGY N COUGH PMAX 16CT SKU 903335 NYQUIL SEVERE VAPOCOOL LIQUID 8 FL OZ SKU 999542 AS PLUS MAX STRNGTH SINUS CONG N PN 20CT SKU 903334 GS DAYTIME COLD FLU RLF ORANGE 12FL OZ SKU 900576 NYQUIL SEVERE COLD FLU BERRY 8 FL OZ SKU 903759 NYQUIL ORGNL COLD AND FLU LQD 12FL OZ SKU 900207 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 900205; 900523; 902012; 917523; 903037; 902906; 902908; 903333; 903335; 999542; 903334; 900576; 903759; 900207
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1454-2022
-
Class II Ongoing
ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901880 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901880 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 919471 ; 901880
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1453-2022
-
Class II Ongoing
READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRAPE 4 FL OZ SKU 999368 GOOD SENSE ALLERGY CETIRIZINE 10 MG TABLET 14 CT SKU 916897 distributed to specific Family Dollar Stores 04/30/2022 through…
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRAPE 4 FL OZ SKU 999368 GOOD SENSE ALLERGY CETIRIZINE 10 MG TABLET 14 CT SKU 916897 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 900448; 999368; 916897
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1452-2022
-
Class II Ongoing
CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG TABLETS 5 CT SKU 916116 GS ALLERGY LORATADINE TABLET 30 CT SKU 916114 CLARITIN ALLERGY 10 MG TABLET 10 CT SKU 901655 distributed to specific Fami…
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG TABLETS 5 CT SKU 916116 GS ALLERGY LORATADINE TABLET 30 CT SKU 916114 CLARITIN ALLERGY 10 MG TABLET 10 CT SKU 901655 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 900834; 916116; 916114; 901655
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1451-2022
-
Class II Ongoing
QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY…
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY CHERRY 4 FL OZ SKU 916917 BENADRYL ALLERGY CONGESTN ULTRA TAB 24CT SKU 999834 BENADRYL ALLERGY ULTRATAB 24CT SKU 902217 BENADRYL ALLERGY LIQUIDGELS 24 CT SKU 916715 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 900449; 916003; 916918; 901738; 916917; 999834; 902217; 916715
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1450-2022
-
Class II Ongoing
GS ANTI DIARRHEAL LOPERAMIDE CAPLET 12 CT SKU 915632 IMODIUM AD MINT 4 OZ SKU 902080 IMODIUM AD CAPLET 6 CT SKU 915628 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- GS ANTI DIARRHEAL LOPERAMIDE CAPLET 12 CT SKU 915632 IMODIUM AD MINT 4 OZ SKU 902080 IMODIUM AD CAPLET 6 CT SKU 915628 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 915632 ; 902080; 915628
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1449-2022
-
Class II Ongoing
GUARDIAN BISMUTH CHWBLE CHRY TABS 30 CTSKU 902321 RIC BISMUTH MAXIMUM STRENGTH 8 FL OZ SKU 914325 PEPTO BISMOL ORIGINAL 8 FL OZ SKU 914324 RIC BISMUTH REG STRENGTH CHERRY 8 FL OZ SKU 914781 PEPTO BISMOL CHERRY 8 FL OZ SK…
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- GUARDIAN BISMUTH CHWBLE CHRY TABS 30 CTSKU 902321 RIC BISMUTH MAXIMUM STRENGTH 8 FL OZ SKU 914325 PEPTO BISMOL ORIGINAL 8 FL OZ SKU 914324 RIC BISMUTH REG STRENGTH CHERRY 8 FL OZ SKU 914781 PEPTO BISMOL CHERRY 8 FL OZ SKU 916063 PEPTO B LIQUID ORIGINAL TRAVEL 3.4 FL OZ SKU 999812 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 902321; 914325; 914324; 914781; 916063; 999812
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1448-2022
-
Class II Ongoing
JOHNSONS BABY FIRST TOUCH GIFT SET 4PC distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Lots / codes
- SKU: 999553
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1447-2022
-
Class II Ongoing
EXCEDRIN MIGRAINE CAPLET 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Lots / codes
- SKU: 913722
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1446-2022
-
Class II Ongoing
NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Lots / codes
- SKU: 902014
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1445-2022
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 4, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.