FDA Drug recall D-057-2013
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSV…
- FDA Drug
- Class I
- ongoing
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class I recall of HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSV… by Vintage Pharmaceuticals, citing superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-057-2013 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2012-09-10 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vintage Pharmaceuticals |
| Distribution | US |
Product
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
Reason
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Identifiers
| code_info | Lot number: C1440512A, Exp 12/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.
Other recalls by Vintage Pharmaceuticals
- HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0…
FDA Drug · Class III · 2017-05-31 · Vintage Pharmaceuticals - DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
FDA Drug · Class III · 2017-02-01 · Vintage Pharmaceuticals - TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-589…
FDA Drug · Class III · 2017-01-11 · Vintage Pharmaceuticals - HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL…
FDA Drug · Class II · 2015-11-25 · Vintage Pharmaceuticals - RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only
FDA Drug · Class III · 2015-11-11 · Vintage Pharmaceuticals
All Vintage Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-057-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.